Articulator of length 260 - Helmut Zepf (85.182.03) - Delynov

What is the Helmut Zepf length 260 presser?

The length 260 presser, bearing reference 85.182.03, is a manual instrument developed by Helmut Zepf Medizintechnik GmbH. Designed in medical stainless steel, this device is intended for professional use in oral surgery. Its robust structure is adapted to the requirements of the clinical environment, offering a reliable solution for the handling of surgical materials. As a Class I device, it meets the rigorous manufacturing standards of the Helmut Zepf brand, ensuring consistent integration into the dental care protocol. This instrument is delivered non-sterile and requires a full cycle of cleaning and sterilization before its first use.

What are the clinical indications for this surgical presser?

The Helmut Zepf surgical presser is indicated as a manual dental instrument for various procedures in oral surgery and implantology. Although MDR specifications do not detail every procedure, this type of instrument is classically used to compact or position filling materials, gauze, or other devices during specific operative phases. Its role is to assist the practitioner in the holding or compression necessary for the success of the procedure. It is exclusively suitable for trained healthcare professionals, who must verify the compatibility of this instrument with other devices used during the surgical procedure to ensure optimal patient safety.

What are the technical characteristics of device 85.182.03?

This Helmut Zepf device is distinguished by its total length of 260mm, offering a reach adapted to the needs of dental surgery. Manufactured from medical grade stainless steel, it exhibits high resistance to corrosion, a sine qua non condition for repeated reprocessing cycles. As a Class I instrument, its design follows the directives relating to non-invasive or transiently invasive medical devices. The manufacturer, Helmut Zepf Medizintechnik GmbH, specifies that due to its design and the materials used, there is no defined maximum limit for treatment cycles, as long as the instrument does not show visible damage such as cracks, breaks, or defects on the functional surfaces.

What are the contraindications for the use of this instrument?

The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity reactions. Metal intolerance in a patient can lead to adverse reactions upon contact with the medical stainless steel of the instrument. If such a hypersensitivity reaction is triggered or suspected, the procedure must be stopped immediately and necessary medical measures must be taken. It is therefore imperative to check the patient's allergic history before any intervention. Furthermore, the use of an instrument showing signs of wear, cracks, or damaged edges is strictly prohibited to avoid any risk of complication during the surgical procedure.

What are the maintenance and sterilization precautions?

The length 260 presser is delivered non-sterile by Helmut Zepf Medizintechnik GmbH. Before the first use, as well as before each subsequent use, the instrument must undergo a complete cleaning, disinfection, and sterilization protocol. The practitioner must carefully inspect the device to detect any visible damage such as cracks or breaks. The use of damaged or worn products is prohibited. Being a non-resorbable stainless steel instrument, its durability depends on the rigor of the reprocessing. It is essential to follow the manufacturer's safety instructions to maintain the integrity of the steel and ensure the asepsis necessary for oral surgery.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This surgical presser is classified as a Class I medical device according to the current regulations (Class Ir - MDC0483 mentioned in the reference texts). The manufacturer guarantees that the instrument is designed in medical stainless steel suitable for temporary human contact in a surgical environment. Compliance with these standards ensures that the product meets the safety and performance requirements for healthcare professionals. Each instrument must be checked before use to confirm its compatibility with clinical standards and the absence of structural defects.

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Surgical medical consumables play a decisive role in operative safety.